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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage low libido in females to now encompass postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional women’s health experts voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be significant to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the available data.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises waiting at least two hours after drinking before taking the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, showed no additional risk of fainting. But experts had reservations.

“This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of females who may find help.

“I do think it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for boosting libido are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”